I am guessing this stands to be topic for all in the Pharma business to keep an eye on. There are those in the Indian government too with reservations. The whole idea here is to save money over what the same might cost in the US, as reported earlier, 1/5 is the cost for R and D, thus this is part of the process and China is also another frontier.
On the other side of the coin, our global citizens may need to hold on to their hats as the R and D roller coaster begins, as mentioned above there will be room for 4 additional failures for the same cost, and with shorter times to collect and evaluate clinical information before releasing to clinical trials, there could be some real issues in time evolve, again reflective on what class of drug and what diseases are being treated. BD 
The news comes just weeks after the Indian media and members of its congress expressed their dismay at the state of India’s clinical trials, following the revelation that 49 infants died at the All India Institute of Medical Scientists (AIIMS).
Congress spokesman Manish Tiwari responded to the news by saying that multinational pharmaceutical companies were treating Indian infants like “guinea pigs”.
The news comes just weeks after the Indian media and members of its congress expressed their dismay at the state of India’s clinical trials, following the revelation that 49 infants died at the All India Institute of Medical Scientists (AIIMS).
Congress spokesman Manish Tiwari responded to the news by saying that multinational pharmaceutical companies were treating Indian infants like “guinea pigs”.
The outsourcing of Phase I trials to India may be allowed by 2009-10 after the Central Drugs Standard Control Organisation (CDSCO) said it is considering changing its stance.
Currently Phase I trials are only allowed if the compound was discovered in India or if data from other markets is submitted, which has restricted the outsourcing of early stage research to India.
The CDSCO’s proposals would overturn this and also allow foreign companies to conduct Phase 0 trials in India.
A reversal of the government’s stance would offer another cost-cutting route for pharmaceutical companies and further swell India’s blossoming clinical trials industry.
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